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South Korea MFDS registration In Vitro No. 22-378

Personal blood glucose meter

KO: 개인용혈당측정기
South Korea flagSouth Korea·Unknown·iSense Wonju Factory·Approved Jun 10, 2022
Basic information
Item Serial Number
2022002973
License Number
In Vitro No. 22-378
체외제허22-378호
Classification Number
J04010.01
Device Class (Risk Classification)
Unknown
Classification Name
Personal blood glucose meter
개인용혈당측정기
Official English Name
Blood glucose meter for self test
Company information
Entity Name (Company)
iSense Wonju Factory
(주)아이센스원주공장
Category
In Vitro Diagnostic Manufacturing
체외진단제조업
Business License Number
체외 제 2624 호
Important dates & status
Item Approval Date
Jun 10, 2022
Business Permit Date
Feb 05, 2008
Model information
Model Name
alphacheck CareSens Dual (GM01HAC)
About this record

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro No. 22-378. Approved on Jun 10, 2022. Registered by iSense Wonju Factory.

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